FDA.reportPublic FDA data

NEXA NPWT DRESSING -125mmHg

Primary DI
15060826400011
Brand
NEXA NPWT DRESSING -125mmHg
Company
NEXA MEDICAL LIMITED
Model
414-00-101
Device description
Nexa NPWT dressing -125mmHg pressure level. To be used in conjunction with Nexa Device and Nexa Fluid Container Pack
Published
2023-08-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OMPNegative Pressure Wound Therapy Powered Suction Pump

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMPNegative Pressure Wound Therapy Powered Suction PumpGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162610000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162610000NEXA Negative Pressure Wound Therapy SystemNexa Medical , Ltd.2017-06-08OMP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060826400011PackageGS15In Commercial Distribution
35060826400015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1506082640001115060826400011
3506082640001535060826400015

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure wound therapy system dressing setA collection of devices that composes a sterile dressing pack used with the pump and collection container of a negative pressure wound therapy (NPWT) system to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic) and diabetic/pressure ulcers. It typically includes dressing (e.g., open-cell foam or medicated gauze), an airtight adhesive drape, a drain, an evacuation tube, and sterile saline. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+441202575749info@nexamedical.com

Regulatory Flags#

DUNS number
221046947
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
25060826400056NEXA Drape414-00-6012023-08-30
25060826400063Nexa Foam414-00-7012023-08-30
35060826400015NEXA NPWT DRESSING -125mmHg414-00-1012023-08-30
35060826400039NEXA NPWT FLUID CONTAINER PACK414-00-1022023-08-30
15060826400004NEXA NPWT Device Kit414-00-3002023-08-30
15060826400059NEXA Drape414-00-6012023-08-30
15060826400066Nexa Foam414-00-7012023-08-30
15060826400035NEXA NPWT FLUID CONTAINER PACK414-00-1022023-08-30

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